TransNasal Insufflation for obstructive sleep apnoea (OSA)

ISRCTN ISRCTN00260427
DOI https://doi.org/10.1186/ISRCTN00260427
Secondary identifying numbers MR-0739-TNI-SS
Submission date
27/03/2008
Registration date
29/04/2008
Last edited
29/04/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr David White
Scientific

1505 Commonwealth Ave
4th floor
Brighton
02135
United States of America

Study information

Study designSingle site, efficacy, proof of concept trial.
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymTNI
Study objectivesH1: Transnasal insufflation (TNI) will reduce significantly the apnoea/hypopnoea index (AHI) and the arousal index (ArI) in newly diagnosed patients with obstructive sleep apnoea (OSA). Apnoeas and hypopnoeas will be examined separately in post hoc analyses. The first hypothesis will be assessed by comparing the AHI at each overnight visit (diagnostic and TNI) employing a paired t-test. If significant findings are obtained, paired t-tests will be employed to examine separately apnoeas and hypopnoeas.

H2: Patients will rate the comfort of TNI and their confidence to use the device nightly. Hypothesis two will be assessed by collating comfort ratings and examining them visually. These ratings will also be correlated with adherence data.

H3: Adherence to TNI will be better than historical averages of positive airway pressure (PAP) adherence (e.g., four hours per night). Hypothesis three will be assessed by collating adherence monitoring and comparing these data to historical controls on PAP.
Ethics approval(s)Ethics approval received from Allendale Investigational Review Board on the 6th December 2007.
Health condition(s) or problem(s) studiedObstructive sleep apnoea
InterventionThis is a within-subjects study of the efficacy of TNI at reducing sleep disordered breathing (SDB) in participants with newly diagnosed sleep apnoea. Thirty participants with diagnosed OSA will be recruited after a standard diagnostic polysomnographic (PSG) study. For the purposes of this study, if a split night study is completed and PAP titration is initiated, subjects will still be considered naive.

Individuals who agree to participate in the study will be provided TNI during an overnight PSG. TNI will be set at 22 lpm for all participants. PSG acquisition will follow standard guidelines for diagnosis, but TNI will be operative during the TNI PSG. Participants will be questioned as to their perceived comfort and ease of therapy the morning after the TNI PSG. Participants will then be sent home with the device. Contact will be made at one week to assess comfort, ease of use and adherence. The final assessment of comfort, ease of use and adherence will occur between 14 - 30 days with TNI. At the termination of the study the patients will undergo a second standard PSG with TNI in place. TNI will be set at 22 lpm for all participants. PSG acquisition will follow standard guidelines for diagnosis, but TNI will be operative during the TNI PSG.

Participants will then be referred for standard clinical treatment as clinically indicated by their original diagnostic PSG. Those participants who elect to receive PAP treatment will be asked if they are willing to fill out a similar comfort questionnaire and to have adherence monitored 14 - 30 days after the start of PAP therapy. Willing participants will receive one additional assessment phone call after 14 - 30 days. Their responses to the questions will be recorded for later analysis.
Intervention typeOther
Primary outcome measureThere are four primary dependent variables for this study:
1. AHI
2. Arousal index
3. Treatment adherence, and
4. Perception of treatment

AHI and arousal index will be monitored with overnight PSG and comparisons will be made between the baseline, diagnostic PSG and the two PSGs with TNI (initiation and termination). TNI adherence will be monitored objectively by equipping the TNI device with an objective monitor of use time. This will be accomplished using a small infra-red sensor that will be mounted to the cannula and worn by the patient when TNI is operating. The signal will be sent to a Palm Pilot where the objective compliance data will be recorded and downloaded. Adherence is a complicated variable and, if not normally distributed, may be categorised based upon accepted definitions. In such a case, these categories would be employed as dependent measures of this outcome variable (e.g., percentage patients averaging four hours/night and six hours/night). All participants will be informed that adherence will be monitored to reduce deception. Adherence will be compared to historical controls with PAP therapy. Comfort ratings will be obtained along with patient preference during the course of the study, including with PAP on those participants agreeing to be followed with traditional treatment. Comfort ratings will also be correlated with adherence as a validation of the comfort scale. We will also incorporate measures of self-efficacy for OSA treatment. Self-efficacy has been a strong predictor of long-term adherence and will provide insight into one potential mediator of adherence across conditions.
Secondary outcome measuresNo secondary outcome measures
Overall study start date12/01/2007
Completion date12/01/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants30
Key inclusion criteria1. Aged 21 - 65 years, either sex
2. Diagnosis of OSA with a baseline AHI between 15 and 50 events/hour of sleep
3. Able and willing to provide written informed consent
4. English speaking
Key exclusion criteria1. Participation in another interventional research study within the last 30 days
2. Major controlled or uncontrolled medical condition such as congestive heart failure, neuromuscular disease, renal failure etc.
3. Prior PAP use or treatment for OSA, excluding split-night PAP exposure
4. Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe chronic obstructive pulmonary disease (COPD), or any condition with an elevation of arterial carbon dioxide levels while awake (PaCO2 greater than or equal to 55 mmHg)
5. Presence of untreated, non-OSA related sleep disorders, e.g., moderate to severe restless legs (Periodic Limb Movement Index [PLMI] greater than or equal to 10) or insomnia
6. Body mass index (BMI) greater than 40 kg/m^2. Most subjects will have a BMI less than or equal to 35 kg/m^2 but we will include a small subset of subjects with a BMI greater than 35 kg/m^2 but less than or equal to 40 kg/m^2.
7. Severe sleepiness (automobile accident or near accident in the last 12 months due to sleepiness)
8. Severe oxygen desaturation on the polysomnography (PSG) (oxygen saturation [Sa02] less than 70% for 10% of the diagnostic PSG study)
9. Surgery of the upper airway, nose, sinus or middle ear within the past 90 days
10. Currently using supplemental oxygen
11. Regular use of sleeping pills or stimulants
12. Currently working night shift or rotating day/night shift

There will be no exclusion based on gender, race or ethnicity.
Date of first enrolment12/01/2007
Date of final enrolment12/01/2008

Locations

Countries of recruitment

  • United States of America

Study participating centre

1505 Commonwealth Ave
Brighton
02135
United States of America

Sponsor information

Respironics, Inc. (USA)
Industry

1001 Murry Ridge Lane
Murrysville
15668
United States of America

Website http://www.respironics.com
ROR logo "ROR" https://ror.org/03kw6wr76

Funders

Funder type

Industry

Respironics, Inc. (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan